The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI).

This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site.

Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.

Inclusion Criteria:

• suspected exocrine pancreatic insufficiency
• at least 18 years of age.

Exclusion Criteria:

• diarrhea (stool water content ≥ 75%) at the time of sample collection

Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Following patient groups show an increased risk for developing an exocrine insufficiency: chronic pancreatitis, cystic fibrosis, diabetes, pancreatic resection. Eligible study subjects provide one stool sample which is forwarded to the study site within three days.